Implementing sensor-based digital health technologies in clinical trials: Key considerations from the eCOA Consortium.

Elena S Izmailova¹, Danielle Middleton², Reem Yunis³, Julia Lakeland⁴, Kristen Sowalsky⁵, Julia Kling¹, Alison Ritchie⁶, Christine C Guo⁷, Bill Byrom⁸, Scottie Kern⁹

¹Koneksa Health, New York, New York, USA.

²AstraZeneca PLC, Cambridge, UK.

³Medable, Inc, Palo Alto, California, USA.

⁴uMotif Ltd, London, UK.

⁵APDM Wearable Technologies, a Clario Company, Portland, Oregon, USA.

⁶Parexel International, Sheffield, UK.

⁷ActiGraph LLC, Pensacola, Florida, USA.

⁸Signant Health, London, UK.

⁹Critical Path Institute, Tucson, Arizona, USA.

PubMed PMC DOI PDF

Abstract

The increased use of sensor-based digital health technologies (DHTs) in clinical trials brought to light concerns about implementation practices that might introduce burden on trial participants, resulting in suboptimal compliance and become an additional complicating factor in clinical trial conduct. These concerns may contribute to the lower-than-anticipated uptake of DHT deployment and data use…

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